Study

Studying Sotagliflozin to Help Slow Kidney Damage in People with Type 1 Diabetes: SugarNSalt Trial

This study wants to learn more about whether a drug called sotagliflozin (SOTA) can slow down the loss of kidney function in people with type 1 diabetes and diabetic kidney disease.

Why this Research Matters

Drugs like SOTA can lower blood glucose and improve heart health in people with diabetes. They may also help slow kidney damage in people with type 2 diabetes. However, we do not know if SOTA can slow down kidney damage in people with type 1 diabetes. The FDA has approved the use of SOTA for this study. This study will compare how quickly kidney function gets worse in people with type 1 diabetes who take SOTA to those who do not take it. If you join, you will be randomly placed into one of two groups, like flipping a coin. The first group will take SOTA every morning after breakfast. The other group will take a placebo every morning after breakfast. A placebo looks like SOTA but contains no active medicine. You will have a total of 19 study visits with 18 visits being in-person at the Barbara Davis Center for Diabetes and one phone visit. If you live far away or cannot travel, up to 5 of the 18 visits can be done remotely. Each study visit will take 2 hours or less. At most of the visits, your medical history, medications, and diabetes therapy will be reviewed. You will also have your height, weight, and vital signs checked and get diabetes ketoacidosis education. You will also have your blood drawn from a vein in your arm. At some of the visits, you will have a physical exam, an ECG to check your heart health, and have your urine collected. You will also wear a continuous glucose monitor if you are not already using one and use a beta-hydroxybutyrate (BHB) monitor to check your ketone levels in your blood. You will not be charged for any study related tests, procedures, or medications. You will be paid $50 for competing each study visit, for a total of $950 if you complete all study visits. You can keep the glucose and BHB monitors after the study ends. This study will take place over about 3 years and 4 months.

Who can Participate

Adult

You may join this study, if you are 18 to 75 years old, have had Type 1 Diabetes for at least 8 years, and have signs of kidney problems related to diabetes.